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The gene therapy developer, uniQure NV, has asked for a second meeting with the US Food and Drug Administration to discuss the agency’s recommendation for further clinical development of its candidate therapy for Huntington’s disease AMT-130. The gene therapy is intended as a one-time treatment for Huntington’s, a rare neurodegenerative disorder. uniQure produced data from a Phase 1/2 trial in September 2025 which was intended as a pivotal study leading to a regulatory submission.

argenx SE delivered an operating profit of $1.1 billion for 2025 – its first ever annual operating profit. This was due to a near doubling of the company’s net sales even as large outlays were made for research and development. A continuous, high level of spending on R&D has enabled the company to expand the scope of a novel target for llama-derived antibodies for autoimmune diseases. The company’s main focus is neurology and the lead product is Vyvgart (efgartigimod), which has three approved indications.

The following article is a review of the 2025 earnings of a cohort of European companies and their expectations for 2026

Gilead Sciences Inc has decided to turn a successful collaboration into ownership with an agreement to buy Arcellx Inc, a developer of cell therapies. The offer is for $115 per share in cash and one contingent value right of $5 per share which represents an implied equity value of $7.8 billion payable at the close. The two companies have been collaborating since 2022 on a chimeric antigen receptor (CAR) T cell therapy for patients with multiple myeloma.

Regulatory activity is underway to bring a new treatment for patients with thymidine kinase 2 deficiency (TK2d) to the European market, an ultra-rare disease that is characterised by progressive and severe muscle weakness. On 30 January, the European Medicines Agency issued a positive opinion for the treatment, Kygevvi (doxecitine and doxribtimine). It is expected to be reviewed by the European Commission in the second quarter for a marketing authorisation decision.

France-based Abivax SA has disclosed evidence that obefazimod, its small molecule drug candidate for inflammatory bowel disease and the subsets Crohn’s disease and ulcerative colitis, has shown evidence of anti-fibrotic activity. This has been illustrated in both preclinical human fibroblast and in vivo animal models of the disease. The data were presented at the European Crohn’s and Colitis Organization’s 21^st Annual Congress in Stockholm on 21 February.

A non-invasive device using electrical fields to disrupt cancer cell division was approved by the US Food and Drug Administration on 12 February. Developed by Novocure Ltd, the therapy is designed to treat locally advanced pancreatic cancer and can be used in a home care setting. It is administered through electrically insulated adhesive patches that are placed on a patient’s skin and connected to an electric field generator.

A vaccine developed by GSK Plc and approved for the prevention of lower respiratory tract disease caused by the respiratory syncytial virus (RSV) appears to have a wider benefit, according to a retrospective study of patients who have received the drug. The study results were presented at a conference in Italy on 17 February. The vaccine, Arexvy, protects against respiratory syncytial virus which causes infections in the lungs and respiratory tract. The virus is common but the effects are most serious for young children and older adults.

After initially refusing to review a candidate mRNA vaccine developed by Moderna Inc for influenza, the US Food and Drug Administration has reversed itself and agreed to consider the product for a marketing authorisation. The decision was announced by Moderna on 18 February and follows a meeting between the agency and the company during which a compromise was reached. 

Moderna Inc has asked for a meeting with the US Food and Drug Administration to query the agency’s decision to refuse to review its candidate mRNA vaccine for influenza. Effective 16 February, the agency hadn’t disclosed whether or not it would consider a follow-up discussion known as a Type-A meeting. This follows an event in early February when the director of the FDA’s biologics evaluation and research division at the agency, Vinayak Prasad, issued a refusal-to-file letter to Moderna overruling the advice of career staff at the agency.